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ihtEvolve 2.5(SC)/2, 75(NC)x30mm

by Iberhospitex, S.A.

Ref 0067255

Expiring European Union

CE MDR CE MDD

Valid until

10 Oct 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberES22/00000630 Date11 Jul 2025IssuedStatusExpiring expires 10 Oct 2027
European UnionCE/MDD NumberB-08428097933209 Basic UDI-DI 08428097933209UDI-DIDate27 Jun 2022RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • ES25/00000120 Active

    Technical documentation EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    7 Jul 2025
    Expires
    5 Feb 2030
  • ES22/00000630 Expiring Supplemented Expires in 338 days

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    11 Jul 2025
    Expires
    10 Oct 2027
    Reason
    Change approved

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Expiring

Specification

EUDAMED

Device Name
PTCA Dilatation Catheter
Model / Reference
0067255
Primary DI / UDI-DI
08428097933209
Basic UDI-DI
B-08428097933209, 8428097PTCA9V
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000160

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

Other devices from Iberhospitex, S.A.

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Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No